Prepares timely pharmacovigilance reports for products and safety issues, Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR), Periodic Reports (PRs) line listings, and other aggregate reports.
¨ Generation of DSUR or other periodic report timelines/project plan, share with stakeholders and reviewers (and client) for agreement on review timelines
¨ If applicable, arrange DSUR/ Periodic reports kick off meeting with required participants and DSUR stakeholders
¨ Ensuring critical resources are available during the process (i.e. Submissions team, Publishing services, etc.)
¨ Coordinating efforts from multiple parties involved with the periodic report/ DSUR process (including internal groups and clients) to ensure responsibilities are clearly defined and the DSUR project plan is successfully implemented within projected timelines
¨ Facilitating the collection of study data from multiple parties (i.e. Data Management, Biostatistics, Clinical, client teams, etc.) within projected timelines
¨ Coordinating and overseeing publishing services
¨ Drafting and finalizing DSUR or other periodic reports within projected timelines
¨ Ensuring timely provision of finalized fully executed report to client and Submissions team in order to successfully meet submission deadlines
¨ Reviewing and providing editing recommendations/guidance for DSURs / periodic reports drafted by other team members.
¨ May execute routine quality review of AE reports and aggregate reports for other members of the group ensuring that case processing and data quality meet global regulatory compliance needs including audit support.
¨ Maintain a strong understanding of Labcorp’s safety database conventions or client-specific database conventions, as appropriate.
¨ Participate in signal detection, trend and pattern recognition activities, as appropriate.
¨ Maintains a comprehensive understanding of Covance PSS’ Standard Operating Procedures (SOPs), Work Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
¨ Demonstrate role-specific Competencies on a consistent basis.
¨ Demonstrate company Values on a consistent basis.
¨ Assist PSS management to identify out of scope work.
¨ Prepare and/or participate in client or regulatory audits.
¨ Any other duties as assigned by management.
- Non-degree + 5 yrs safety experience*
- Associate degree + 4 yrs safety experience*
- Associate degree RN + 4 yrs safety experience*
- BS/BA + 3 yrs safety experience*
- MS/MA + 2 yrs relevant experience** (1-2 yrs safety experience)
- PharmD + 1 yrs relevant experience** (1 yr safety experience)
For PharmD, a one year residency of fellowship can be considered relevant experience.
Degree preferred to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
*Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
- Good verbal, written and presentation skills.
- Good communication.
- Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
- High degree of accuracy with attention to detail.
- Functions as a team player.
- Ability to present and share useful business information across departments and functions.
- Ability to anticipate and identify problems and take appropriate action to correct.
- Knowledge of medical and drug terminology
- Knowledge of Good Clinical Practice (GCP) related to clinical safety documentation
- Knowledge of ICH Guidelines
- Knowledge of Medical Device reporting desirable
- Knowledge of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products.
- Good knowledge and understanding of industry and R&D processes and objectives.
- Ability to work independently with minimal supervision
- Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial
Apply : https://drugdevelopmentcareers.labcorp.com/global/en/job/COVAGLOBAL77041EXTERNAL/Safety-Reporting-Specialist?utm_source=linkedin&utm_campaign=linkedin&mode=apply&iis=Jobboard&iisn=Linkedin&utm_medium=phenom-feeds